PROTECTED NEEDLE WITH OR WITHOUT IV SET

PROTECTED NEEDLE WITH OR WITHOUT IV SET is an FDA 510(k)-cleared medical device (K903809) manufactured by Kendall Mcgaw Laboratories, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 1990. Regulation: 8.